Factors associated with severe maternal outcome in patients admitted to an intensive care unit in northeastern Brazil with postpartum hemorrhage: a retrospective cohort study.

BACKGROUND: Postpartum hemorrhage (PPH) is the leading cause of maternal death worldwide, particularly in low- and middle-income countries; however, the majority of these deaths could be avoided with adequate obstetric care. Analyzing severe maternal outcomes (SMO) has been a major approach for evaluating the quality of the obstetric care provided, since the morbid events that lead to maternal death generally occur in sequence. The objective of this study was to analyze the clinical profile, management, maternal outcomes and factors associated with SMO in women who developed PPH and were admitted to an obstetric intensive care unit (ICU) in northeastern Brazil. METHODS: This retrospective cohort study included a non-probabilistic, consecutive sample of postpartum women with a diagnosis of PPH who were admitted to the obstetric ICU of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) between January 2012 and March 2020. Sociodemographic, biological and obstetric characteristics and data regarding childbirth, the management of PPH and outcomes were collected and analyzed. The frequency of maternal near miss (MNM) and death was calculated. Multiple logistic regression analysis was performed to determine the adjusted odd ratios (AOR) and their 95% confidence intervals (95% CI) for a SMO. RESULTS: Overall, 136 cases of SMO were identified (37.9%), with 125 cases of MNM (34.9%) and 11 cases of maternal death (3.0%). The factors that remained associated with an SMO following multivariate analysis were gestational age ≤ 34 weeks (AOR = 2.01; 95% CI: 1.12-3.64; p < 0.02), multiparity (AOR = 2.20; 95% CI: 1.10-4.68; p = 0.02) and not having delivered in the institute (AOR = 2.22; 955 CI: 1.02-4.81; p = 0.04). CONCLUSION: Women admitted to the obstetric ICU with a diagnosis of PPH who had had two or more previous deliveries, gestational age ≤ 34 weeks and who had delivered elsewhere were more likely to have a SMO.

Prognostic scores for prediction of maternal near miss and maternal death after admission to an intensive care unit: A narrative review.

Near miss morbidity and maternal death (defined as severe maternal outcomes - SMO) are the most important adverse outcomes in obstetric settings to assess delays and characteristics of health care management. Intensive care units (ICUs) represent an opportunity of adequate care for women who, in several cases, experienced earlier clinical delays in their maternal health care management. Some prognostic scores widely used in ICU have been useful in characterizing patients in terms of severity of illness in clinical studies, for evaluation of ICU performance, in quality improvement initiatives and for benchmark purposes. Prediction of SMO during the admission to the ICU could greatly improve obstetric care management. We reviewed the feasibility of the existing ICU clinical and obstetric prediction scores in predicting maternal near miss and maternal death.

Effectiveness of the peanut ball use for women with epidural analgesia in labour: a systematic review and meta-analysis.

This meta-analysis aimed to evaluate, using the best level of evidence, the possible benefits and advantages of using peanut ball (PB) in women with an epidural during labour on the maternal and neonatal outcomes. This research was conducted using MEDLINE/PubMed, Embase, LILACS, CINAHL, CENTRAL, PEDro, Web of Science and SCOPUS databases, with no period or language restrictions. The terms 'labor' and 'peanut ball' were used. Clinical trials (randomised and non-randomised) were included when comparing a group of parturients using PB with a control group under usual care. Randomised clinical trials (RCTs) or quasi-randomised were eligible for this systematic review. Two reviewers independently screened studies, extracted data and assessed the quality of evidence which was evaluated by the GRADE system. Quantitative analysis through meta-analysis was also applied whenever possible. In this updated review, we included four studies with a total of 818 women in labour after the use of pharmacological analgesia. Our GRADE ratings of evidence ranged from high to low quality. Overall, the included studies varied in their risk of bias, in which most were considered with some concerns. There is high evidence that the use of PB after epidural analgesia reduces the duration of the first period of labour by 87 minutes and moderate evidence that it increases the chance of vaginal delivery 11%. However, there is no evidence about other maternal and neonatal outcomes.Impact StatementWhat is already known on this subject? The peanut ball (PB) is used after the use of pharmacological analgesia, as it favours the opening of the pelvic canal and helps women to adopt more comfortable postures, but its real effects are not clear.What do the results of this study add? Our results suggest that using the PB reduces the duration of the first period of labour after an epidural and increases the chance of a vaginal birth.What are the implications of these findings for clinical practice and/or further research? These findings recommend the use of a PB after an epidural and further research with women without the use of pharmacological analgesia.

"Preterm birth risk, me?" Women risk perception about premature delivery - a qualitative analysis.

BACKGROUND: Risk perception is based on collective indicators, but it is influenced by the individual's self-perception of his health-disease process. This study aims to investigate the risk perception of pregnant women who were identified as high-risk for premature birth and to seek strategies for better management of such cases. METHODS: This is a cross-sectional study where women who had completed their participation in P5 trial were contacted and invited to answer a structured questionnaire with open questions. Data were collected by telephone and analyzed using thematic analysis. The analysis categories were defined, and all the answers were reviewed, categorized, grouped, and a descriptive summary was prepared. RESULTS: Two hundred eight Brazilian women have participated. Three categories were identified: (1) Risk perception mediated by health professionals; (2) Self-perception of risk through personal experiences and relationships; (3) Perception of treatment success. After receiving an explanation from a health professional about short cervix and premature birth, women understood the risk of premature delivery, recognizing the importance of early diagnosis to prevent premature birth. Unsuccessful previous experiences in prior pregnancies influenced women's risk perception. Patients believed in the success of the treatment performed, placing their hopes on the treatment even without research guarantees about benefits. CONCLUSIONS: Pregnant women's risk perception regarding prematurity is based partly on personal and family experiences but mainly on information given by health professionals. The risk perception about preterm birth may contribute to healthy pregnancy, guiding necessary interventions and preventing adverse outcomes. Prevention studies on prematurity should thus focus on neonatal outcomes.

Maternal near miss determinants at a maternity hospital for high-risk pregnancy in northeastern Brazil: a prospective study.

BACKGROUND: To investigate the association between sociodemographic and obstetric variables and delays in care with maternal near misses (MNMs) and their health indicators. METHODS: A prospective cohort study was conducted at a high-risk maternity hospital in northeastern Brazil from June 2015 to May 2016 that included all pregnant women seen at the maternity hospital during the data collection period and excluded those who had not been discharged at the end of the study or whom we were unable to contact after the 42nd postpartum day for MNM control. We used the MNM criteria recommended by the WHO. Risk ratios (RRs) and their 95% confidence intervals (CIs) were calculated. Hierarchical multiple logistic regression analysis was performed. The p values of all tests were two-tailed, and the significance level was set to 5%. RESULTS: A total of 1094 pregnant women were studied. We identified 682 (62.4%) women without adverse maternal outcomes (WOAMOs) and 412 (37.6%) with adverse maternal outcomes (WAMOs), of whom 352 had potentially life-threatening conditions (PLTCs) (85.4%), including 55 MNM cases (13.3%) and five maternal deaths (1.2%). During the study period, 1002 live births (LBs) were recorded at the maternity hospital, resulting in an MNM ratio of 54.8/1000 LB. The MNM distribution by clinical condition identified hypertension in pregnancy (67.2%), hemorrhage (42.2%) and sepsis (12.7%). In the multivariate analysis, the factors significantly associated with an increased risk of MNM were fewer than six prenatal visits (OR: 3.13; 95% CI: 1.74-5.64) and cesarean section in the current pregnancy (OR: 2.91; 95% CI: 1.45-5.82). CONCLUSIONS: The factors significantly associated with the occurrence of MNM were fewer than six prenatal visits and cesarean section in the current pregnancy. These findings highlight the need for improved quality, an increased number of prenatal visits and the identification of innovative and viable models of labor and delivery care that value normal delivery and decrease the percentage of unnecessary cesarean sections.

Reasons given by pregnant women for participating in a clinical trial aimed at preventing premature delivery: a qualitative analysis.

BACKGROUND: In clinical trials, pregnant women are potentially vulnerable, and the fetus is exposed to the intervention. This study aimed to identify the reasons that led pregnant women at a high risk of premature delivery to participate in a randomized clinical trial. METHODS: The women participating in the main trial were contacted by telephone postpartum and invited to answer an open questionnaire in a cross-sectional study. Data were collected by telephone and analyzed using thematic analysis. After the analysis categories were defined, all the answers were reviewed, categorized and grouped. A descriptive summary of the content of each category was then made. RESULTS: Overall, 208 women from different geographical regions of the country agreed to participate. Four categories were identified: 1) The risk of losing the baby; 2) A previous experience of premature delivery; 3) The role of the doctor and other health professionals, and 4) The availability of quality medical care and free medication. The main reason given for agreeing to participate was to reduce the risks associated with the baby being born prematurely, particularly when the woman herself or someone close to her had already experienced premature delivery. Other reasons were having received clear guidance and explanations from the doctor regarding prematurity and about the study and being given the opportunity to receive free treatment with greater access to the public healthcare system. CONCLUSIONS: The decision to participate in a clinical trial is not easy, particularly when the individual is vulnerable and in a critical situation as in the case of a pregnant woman at a high risk of delivering prematurely. Fears and uncertainties regarding the pregnancy outcome, as well as the woman's previous experiences and her awareness of the actual risks she faces will affect her decision regarding whether or not to participate. Recruitment challenges could be overcome by ensuring that the research team provides adequate information and support, thus creating a bond with participants that would foster a sense of safety and trust in the study proposals.

Correlation between electromyography and perineometry in evaluating pelvic floor muscle function in nulligravidas: A cross-sectional study.

OBJECTIVE: To correlate the results of electromyography and perineometry in the assessment of PFM function in nulligravidas. METHODS: The cross-sectional observational study was approved by the internal review board of the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) and was conducted in the Instituto Paraibano de Pesquisa Professor Joaquim Amorim Neto (IPESQ). Thirty-eight nulligravidas aged 18-39 years of age, who had already initiated their sexual life, participated in the study. Exclusion criteria consisted of the presence of genital prolapse, a history of pelvic or urogenital surgery and the presence of neurological disease producing muscle disorders. For the evaluation procedure, the women were submitted to a clinical evaluation of the pelvic floor muscles followed by electromyography. Perineometry was performed 72 h later. Prior to electromyography and perineometry, the women were given standardized training with electromyographic biofeedback to teach them to contract only their pelvic floor muscles. RESULTS: A highly positive, statistically significant correlation (r = 0.968; P < 0.001) was found between the electromyographic and perineometric findings. CONCLUSIONS: A strong correlation was found between perineometric and electromyographic findings of pelvic floor muscle function.

Neonatal near miss determinants at a maternity hospital for high-risk pregnancy in Northeastern Brazil: a prospective study.

BACKGROUND: To investigate the associations of maternal variables - sociodemographic, obstetrical and maternal near miss (MNM) variables - with neonatal near miss (NNM) using the new concept of NNM formulated by the Centro Latino-Americano de Perinatologia (CLAP) and the corresponding health indicators for NNM. METHODS: An analytical prospective cohort study was performed at maternity hospital for high-risk pregnancy in Northeastern Brazil. Puerperal women whose newborn infants met the selection criteria were subjected to interviews involving pretested questionnaires. Statistical analysis was performed with the Epi Info 3.5.1 program using the Chi square test and Fisher's exact test when appropriate, with a level of significance of 5%. A bivariate analysis was performed to evaluate differences between the groups. All the variables evaluated in the bivariate analysis were subsequently included in the multivariate analysis. For stepwise logistic regression analysis, a hierarchical model was plotted to assess variable responses and adverse outcomes associated with MNM and NNM variables. RESULTS: There were 1002 live births (LB) from June 2015 through May 2016, corresponding to 723 newborn infants (72.2%) without any neonatal adverse outcomes, 221 (22%) NNM cases, 44 (4.4%) early neonatal deaths and 14 (1.4%) late neonatal deaths. The incidence of NNM was 220/1000 LB. Following multivariate analysis, the factors that remained significantly associated with increased risk of NNM were fewer than 6 prenatal care visits (odds ratio (OR): 3.57; 95% confidence interval (CI): 2.57-4.94) and fetal malformations (OR: 8.78; 95% CI: 3.69-20.90). Maternal age older than 35 years (OR: 0.43; 95% CI: 0.23-0.83) and previous cesarean section (OR: 0.45; 95% CI: 0.29-0.68) protected against NNM. CONCLUSION: Based on the large differences between the NNM and neonatal mortality rates found in the present study and the fact that NNM seems to be a preventable precursor of neonatal death, we suggest that all cases of NNM should be audited. Inadequate prenatal care and fetal malformations increased the risk of NNM, while older maternal age and a history of a previous cesarean section were protective factors.

Planned caesarean section versus planned vaginal birth for severe pre-eclampsia.

BACKGROUND: Pre-eclampsia is a very frequent complication of pregnancy, and anticipation of birth is often necessary. However, the best mode of giving birth remains to be established, although observational studies suggest better maternal and perinatal outcomes with vaginal birth. OBJECTIVES: To assess the effects of a policy of planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia on mortality and morbidity for mother and baby. SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (6 September 2017) and reference lists of retrieved studies. SELECTION CRITERIA: We planned to include all randomised trials of planned caesarean section versus planned vaginal birth for pregnant women with severe pre-eclampsia. Quasi-randomised and non-randomised studies are not eligible for inclusion in this review.The focus of this review is severe pre-eclampsia; studies of planned caesarean section versus planned vaginal birth in pregnant women with eclampsia are not eligible for inclusion. DATA COLLECTION AND ANALYSIS: We identified no studies that met the inclusion criteria. We excluded two studies. MAIN RESULTS: There are no included studies in this review. AUTHORS' CONCLUSIONS: There is a lack of robust evidence from randomised controlled trials that can inform practice regarding planned caesarean section versus planned vaginal birth for women with severe pre-eclampsia. There is a need for high-quality randomised controlled trials to assess the short- and long-term effects of caesarean section and vaginal birth for these women and their babies.

Selective episiotomy vs. implementation of a non-episiotomy protocol: a randomized clinical trial.

BACKGROUND: Despite all the evidence corroborating the selective use of episiotomy and although routine use of the procedure is contraindicated, there are no evidences corroborating if episiotomy is necessary in any circumstance. The present clinical randomized trial was performed to compare maternal and perinatal outcomes in women submitted to a non-episiotomy protocol versus one of selective episiotomy. METHODS: An open-labelled, randomized clinical trial was carried out in a tertiary teaching hospital in Recife, Northeastern Brazil. Women in labor with a full-term live foetus, dilatation of 6 to 8 cm and cephalic presentation (vertex position) were included. Exclusion criteria consisted of bleeding disorders and an indication for a caesarean section. After signing the consent form, 241 women were randomized to a non-episiotomy protocol (the experimental group) or to a selective episiotomy group (the control group). No episiotomies were to be performed in the experimental group except under exceptional circumstances. In the control group, selective episiotomies were to be performed in accordance with the healthcare professionals' clinical judgement. Maternal and perinatal outcomes were evaluated. Ratio Risk (RR) and the 95% confidence interval (95% CI) were calculated for our outcomes. RESULTS: The analysis include 115 women assigned to a non-episiotomy protocol and 122 to selective episiotomy. There was no difference between the two groups with respect to maternal or perinatal outcomes. The episiotomy rate was similar (two cases in each group, about 1.7%), as was the duration of the second stage of labor, the frequency of perineal tears, severe perineal trauma, need for perineal suturing and blood loss at delivery. CONCLUSIONS: A non-episiotomy protocol appears to be safe for mother and child, and highlights the need to investigate whether there is, in fact, any indication for this procedure. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov under reference number ( NCT02178111 ).

Diuretics vs. placebo for postpartum blood pressure control in preeclampsia (DIUPRE): a randomized clinical trial.

BACKGROUND: Hypertension affects about 10% of pregnancies and is responsible for both maternal and neonatal devastating complications such as eclampsia, HELLP syndrome, prematurity and maternal and neonatal death. The resolution of the disease occurs in the first twelve weeks postpartum. The behavior of blood pressure and occurrence of very high blood pressure episodes among women with severe preeclampsia is related to remodeling of the dynamics of body fluids with consequent increase in intravascular volume. The persistence of hypertension in critical levels results in increased puerperal morbidity. OBJECTIVES: To evaluate the effectiveness of furosemide in accelerating blood pressure recovery among women with severe preeclampsia. METHODS/DESIGN: A triple-masked placebo controlled clinical trial, will be conducted including 120 postpartum women with severe preeclampsia, after eclampsia prophylaxis with magnesium sulfate and with adequate diuresis. Women with chronic hypertension and users of diuretics will be deleted. Informed consent will be obtained from all participants. Patients will be randomized to receive furosemide (40 mg orally every twenty four hours) or placebo. The variables are systolic and diastolic blood pressure, frequency of hypertensive crises, need for maintenance of antihypertensive therapy, number of antihypertensive agents used to control blood pressure, urine output, length of hospital stay, adverse effects and maternal complications. This study was approved by the Research Ethics Committee in humans of our institution. All participants will be duly informed about the aims of the project and will be included only if they agree to participate voluntarily, signing the informed consent. TRIAL REGISTRATION: This study was registered on Clinical Trials.gov under the number NCT02163655. ( http://clinicaltrials.gov/show/NCT02163655).

Factors associated with severe maternal morbidity and near miss in the São Francisco Valley, Brazil: a retrospective, cohort study.

BACKGROUND: Maternal mortality remains a major public health issue worldwide, with persistent high rates prevailing principally in underdeveloped countries. The objective of this study was to determine the risk factors for severe maternal morbidity and near miss (SMM/NM) in pregnant and postpartum women at the maternity ward of the Dom Malan Hospital, Petrolina, in northeastern Brazil. METHODS: A retrospective, cohort study was conducted to evaluate the sociodemographic and obstetric characteristics of the women. Patients who remained hospitalized at the end of the study period were excluded. Risk ratios (RR) and their respective 95% confidence intervals (95% CI) were calculated as a measure of relative risk. Hierarchical multiple logistic regression was also performed. Two-tailed p-values were used for all the tests and the significance level adopted was 5%. RESULTS: A total of 2,291 pregnant or postpartum women receiving care between May and August, 2011 were included. The frequencies of severe maternal morbidity and near miss were 17.5% and 1.0%, respectively. Following multivariate analysis, the factors that remained significantly associated with an increased risk of SMM/NM were a Cesarean section in the current pregnancy (OR: 2.6; 95% CI: 2.0 - 3.3), clinical comorbidities (OR: 3.4; 95% CI: 2.5 - 4.4), having attended fewer than six prenatal visits (OR: 1.1; 95% CI: 1.01 - 1.69) and the presence of the third delay (i.e. delay in receiving care at the health facility) (OR: 13.3; 95% CI: 6.7 - 26.4). CONCLUSIONS: The risk of SMM/NM was greater in women who had been submitted to a Cesarean section in the current pregnancy, in the presence of clinical comorbidities, fewer prenatal visits and when the third delay was present. All these factors could be minimized by initiating a broad debate on healthcare policies, introducing preventive measures and improving the training of the professionals and services providing obstetric care.

Selective episiotomy vs. implementation of a non episiotomy protocol: a randomized clinical trial.

BACKGROUND: World Health Organization (WHO) recommends that the episiotomy rate should be around 10%, which is already a reality in many European countries. Currently the use of episiotomy should be restricted and physicians are encouraged to use their clinical judgment to decide when the procedure is necessary. There is no clinical evidence corroborating any indication of episiotomy, so until the present moment it is not yet known whether episiotomy is indeed necessary in any context of obstetric practice. OBJECTIVES: To compare maternal and perinatal outcomes in women undergoing a protocol of not performing episiotomy versus selective episiotomy. METHODS/DESIGN: An open label randomized clinical trial will be conducted including laboring women with term pregnancy, maximum dilation of 8 cm, live fetus in cephalic vertex presentation. Women with bleeding disorders of pregnancy, indication for caesarean section and those without capacity to consent and without legal guardians will be excluded. Primary outcomes will be frequency of episiotomy, delivery duration, frequency of spontaneous lacerations and perineal trauma, frequency of instrumental delivery, postpartum blood loss, need for perineal suturing, number of sutures, Apgar scores at one and five minutes, need for neonatal resuscitation and pH in cord blood. As secondary outcomes frequency complications of perineal suturing, postpartum perineal pain, maternal satisfaction, neonatal morbidity and admission newborn in NICU will be assessed. Women will be invited to participate and those who agree will sign the consent form and will be then assigned to a protocol of not conducting episiotomy (experimental group) or to a group that episiotomy is performed selectively according to the judgment of the provider of care delivery (control Group). The present study was approved by IMIP's Research Ethics Committee. TRIAL REGISTRATION: Clinical Trials Register under the number and was registered in ClinicalTrials.gov under the number NCT02178111.

Factors associated with the persistence/recurrence of CIN2/3 in women submitted to loop electrosurgical excision procedure in a teaching hospital in northeastern Brazil: a case-control study.

OBJECTIVE: This study aimed to identify risk factors associated with the persistence/recurrence of cervical intraepithelial neoplasia (CIN) 2/3 in women submitted to loop electrosurgical excision procedure (LEEP) in a hospital in northeastern Brazil. MATERIALS AND METHODS: A case-control study included 50 women with and 50 women without persistence/recurrence of CIN2/3 after LEEP at the Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) between 2004 and 2011. Data were collected from June to December 2011. Inclusion criteria were diagnosis of CIN2/3 during follow-up (cases) and women free of CIN2/3 after a follow-up of 2 years or longer (controls). Exclusion criteria (cases/controls) were LEEP performed at another hospital, LEEP performed for persistent CIN1, invasive carcinoma in the cone specimen or at cytology, and/or histopathology within a 2-year follow-up period. Persistence was defined as residual disease detected in the first year after LEEP, and recurrence was defined as the reappearance of a lesion more than 1 year after surgery. Bivariate analysis was performed for biological, sociodemographic, sexual, reproductive, lifestyle, and clinical variables. Odds ratios (ORs) and their 95% confidence intervals (95% CIs) were calculated, and a multiple logistic regression analysis was performed to control for potential confounding factors. The study was approved by IMIP's internal review board. RESULTS: Multiple logistic regression analysis showed a significant association between persistence/recurrence of CIN2/3 and living outside the capital city (OR=3.11, 95% CI=1.14-8.41), smoking (OR=4.22, 95% CI=1.18-15.05), and positive endocervical margins (OR=6.58, 95% CI=2.37-18.28). CONCLUSIONS: Women with persistence/recurrence of CIN2/3 are more likely to live outside the state capital, be smokers, and have positive endocervical margins, so these women should be followed up more closely.

Active pelvic movements on a Swiss ball reduced labour duration, pain, fatigue and anxiety in parturient women: a randomised trial.

QUESTION: How much do active pelvic movements on a Swiss ball during labour affect maternal and neonatal outcomes? METHOD: A randomised trial with concealed allocation, blinded assessors and intention-to-treat analysis. PARTICIPANTS: Two-hundred parturient women. INTERVENTION: The experimental group performed pelvic anteversion and retroversion, lateral pelvic tilts and circular hip movements according to individual obstetric evaluation (foetal station and position, cervical dilatation and the presence of early pushing urge) on a Swiss ball. The control group received usual care. Both groups were permitted to walk and shower. OUTCOME MEASURES: The primary outcome was the duration of the first stage of labour. The secondary outcomes were the duration of the second stage of labour, pain intensity, delivery mode, medication use, local swelling, fatigue, anxiety, satisfaction and neonatal outcomes. RESULTS: The experimental intervention reduced the duration of labour by 179 minutes (95% CI 146 to 213) in stage one and 19 minutes (95% CI 13 to 25) in stage two. It decreased pain by approximately 2 points (95% CI 2 to 2) on a 0-to-10 scale at 30, 60 and 90 minutes. It reduced the risk of a caesarean section (ARR 0.14, 95% CI 0.03 to 0.25; NNT 7, 95% CI 4 to 32) and vulvar swelling (ARR 0.11, 95% CI 0.03 to 0.19; NNT 9, 95% CI 5 to 31). It reduced fatigue by 18 points (95% CI 16 to 21) on a 15-to-75-point scale and anxiety by 9 points (95% CI 8 to 11) on an 18-to-72-point scale. Other effects were negligible or unclear. CONCLUSION: Active pelvic movements on a Swiss ball during labour reduced the duration of labour, pain intensity, and maternal fatigue and anxiety; they also lowered the risk of caesarean section and vulvar swelling. Several effects exceeded the smallest worthwhile effect. REGISTRATION: NCT04124835.